(162 days)
The Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers are intended for delivery of the stent to the pancreatic duct (PD): · Used to drain pancreatic ducts
The Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers product consists of pancreatic stents and delivery systems or stent pushers. The pancreatic stents are provided in straight or single pigtail shape. The straight shape stents have trailing barbs and/or leading barbs depending on application, a rounded or tapered leading end tip to facilitate access through the papilla, and a rounded trailing end to abut the push catheter portion of the delivery system or stent pusher. The single pigtail stent may or may not have leading end barbs depending on application. Some stents have lateral drainage holes in the pigtails, a tapered or rounded leading end tip, and a rounded trailing end. All stents have either an endoscopic marker, fluoroscopic marker, or both on the trailing or leading end of the stent to assist with depth of placement in the pancreatic duct. The location and presence of an endoscopic or fluoroscopic marker is dependent on the length and diameter size of the stent. Some codes have side port holes in the body of the stent. The Advanix Pancreatic Stent is designed for pancreatic duct (PD) drainage. The stent is constructed of a radiopaque (RO) polymer. The leading end has a tapered or rounded tip and the trailing end of the stent has an endoscopically visible marker to aid in placement. Stent sizes 4F and 5F contain a RO marker while 3F stents do not. The stent is available in two different shapes: straight stent and single pigtail. 3F and 4F stents have no-leading barb; 5F stents are available with and without a leading barb. Stent sizes 7F and 10F contain an RO marker except for the 3cm length stents. The 7F stent is available in two different shapes: straight stent and single pigtail. The 10F stent is only available in the straight stent shape. The pusher is constructed of RO polymer. The trailing end of the pusher has a white indicator to indicate the non-working end. There are 2 pusher options: RX and longwire. The RX pusher has a guidewire exit marker on the leading end to indicate the guidewire exit location. The wire for the longwire pusher exits at the trailing end of the pusher. The delivery system consists of a guide catheter connected to a pull-wire, and a push catheter connected to a locking mechanism. The locking mechanism is designed to keep the guide catheter in the position desired while being delivered to the deployment site. The stent can be deployed by disengaging the locking mechanism and retracting the guide catheter.
The provided document describes a 510(k) premarket notification for a medical device, the Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than robust performance studies with acceptance criteria as one might find for novel devices or software.
Therefore, the document does not contain information regarding traditional acceptance criteria associated with a device's clinical performance (e.g., sensitivity, specificity, accuracy), nor does it describe a study specifically designed to "prove" the device meets such criteria in terms of clinical outcomes or diagnostic accuracy.
Instead, the performance data presented (Section 7) focuses on biocompatibility and physical/mechanical characteristics to demonstrate that the new device is as safe and effective as the predicate devices. The "acceptance criteria" here are implied to be that the new device's characteristics fall within acceptable ranges, similar to or equivalent to the predicate devices, and that it passes standard biocompatibility tests.
Here is a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
As explained above, the document does not present clinical performance metrics like sensitivity or specificity. The "acceptance criteria" are implied by the conducted tests and the substantial equivalence claim.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Evaluation in accordance with EN ISO 10993-1:2009. |
| Stent Biocompatibility | Passed tests for Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Subchronic Toxicity, Genotoxicity, Implant, USP Physicochemical, and Latex. |
| Delivery System/Pusher Biocompatibility | Passed tests for Cytotoxicity, Sensitization, Irritation, USP Physicochemical and Latex. |
| Physical/Mechanical Characteristics | Tests conducted on: Drainage Lumen ID, Stent Length, Stent Outer Diameter, Pigtail Stent Shape, Pigtail Stent Diameter, No-Leading Barb Stent Stiffness, Leading Barb Stent Stiffness, Stent Tensile, Pusher Working Length, Delivery System Working Length, Pusher OD, Delivery System Push Catheter OD, Pusher Deployment Force, Delivery System Deployment Force, Pusher Trackability Force, and Delivery System Trackability Force. (Specific values/acceptance ranges are not provided in the summary, but these tests were performed to demonstrate substantial equivalence to predicate devices.) |
2. Sample Size for Test Set and Data Provenance
- Sample Size (Test Set): Not applicable in the context of this 510(k) summary for clinical performance. The studies performed are bench, lab, and biocompatibility tests, not clinical studies with patient test sets.
- Data Provenance: Not applicable for a traditional clinical "test set." The data comes from internal laboratory testing (biocompatibility, physical/mechanical).
3. Number of Experts and Qualifications for Ground Truth
- This information is not applicable. No "ground truth" using expert consensus (e.g., from radiologists) was established for a test set in this 510(k) submission, as it's not a diagnostic or AI-driven device.
4. Adjudication Method
- Not applicable, as there was no expert review or ground truth establishment for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not a diagnostic device or AI software. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.
6. Standalone Performance Study (Algorithm Only)
- No. This is not an algorithm or AI device.
7. Type of Ground Truth Used
- Not applicable for a clinical "ground truth" to evaluate diagnostic accuracy. The ground truth for the engineering and biocompatibility tests would be the established scientific standards and specifications (e.g., ISO standards, material properties, dimensional tolerances).
8. Sample Size for the Training Set
- Not applicable. There is no AI component or "training set" mentioned in this submission.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no AI component or training set.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.